U.S. judge blocks Massachusetts ban on opioid painkiller Zohydro ER

A federal judge has blocked a Massachusetts regulation meant to restrict sales of Zohydro ER, a powerful opioid painkiller, after Gov. Deval Patrick sought to ban the drug's availability in the state.

U.S. District Judge Rya W. Zobel in Boston said in an order Tuesday that efforts to hamper Zohydro ER prescriptions in Massachusetts were ambiguous, and that Massachusetts lawmakers “may not use vague regulations to sidestep or countermand federal law” for opioid dispensing.

Zohydro ER, approved by the U.S. Food and Drug Administration last year, was released to the market in March. The FDA classifies the extended-release pill, which contains 10 to 50 milligrams of hydrocodone, as a Schedule II controlled substance, meaning it requires a doctor's prescription, and refills are not allowed.

Gov. Patrick declared a public health emergency in Massachusetts in March, saying that prescribing and dispensing of Zohydro ER would be banned in the state until “adequate measures are in place to safeguard against the potential for diversion, overdose and misuse” of the drug.

The Massachusetts Board of Registration in Medicine later issued emergency regulations stating, in part, that prescribers of Zohydro ER or similar drugs must provide a “letter of medical necessity” that “verifies that other pain management treatments have failed” for a patient receiving the drug, court records show. The regulations don't name Zohydro ER specifically but list drug characteristics that apply only to that pill.

The Massachusetts Board of Registration in Pharmacy also required that, among other safety regulations, Zohydro ER or similar pills could only be handled by pharmacists and not a “certified pharmacy technician, pharmacy technician, pharmacy technician trainee, or pharmacy intern,” according to court records.

San Diego-based Zogenix Inc., the maker of Zohydro ER, argued in court filings that the letter requirement and pharmacist restriction were unconstitutional and resulted in a “de facto ban” of the drug in Massachusetts. Zogenix CEO Roger L. Hawley contended in testimony that “unspecified major retail pharmacy chains do not plan to stock Zohydro” because the pharmacist-only regulation is “fundamentally incompatible” with their personnel structure and opioid dispensing policies.

Judge Zobel found Tuesday that the “letter of medical necessity” requirement should be blocked because the requirements for that regulation were too vague, particularly as it relates to showing the failure of other treatments.

“Must a physician try a new treatment — or, because it is plural in the regulation, treatments — before writing each new prescription, or may she rely upon a failed treatment in the more distant past? If she may, how distant?” the ruling reads. “For example, if a physician had prescribed a different opioid six months ago with no success, could she write a prescription for Zohydro and still comply with the '(medical necessity) regulation?' Could a fellow physician rely on a failed regimen of vitamins and acupuncture two months ago?”

“If the Commonwealth interpreted its regulation to require a fresh failure as a precondition to each 30-day Zohydro prescription, it would severely frustrate Zohydro's availability and pose significant constitutional concerns,” the ruling adds.

The injunction against the medical necessity letter can be lifted if Massachusetts provides “adequate and constitutional guidance to physicians regarding the prerequisites for prescribing Zohydro in compliance with the regulation,” the ruling reads.

Judge Zobel denied a request from Zogenix to block the “pharmacist-only” regulation because the company failed to prove that Massachusetts regulations would prevent pharmacies from carrying Zohydro ER.